Effects of oral fixed-dose combinations of telmisartan plus ramipril and losartan plus ramipril in hypertension: A multicenter, prospective, randomized, double-blind, phase iii trial in adult indian patients

• Published in: Current therapeutic research 2005-11, Vol.66 (6), p.630-642
• Main Authors: Jain, S.D., Biradar, Sangram, Periyandavar, I., Singh Sodhi, Sanjeet, Anwaruddin, K., Gawde, Ashish, Baliga, Vidyagauri, Gandewar, Kailas, Desai, Anish
• Format: Article
• Language: English
• Subjects: Biological and medical sciences; losartan; Medical sciences; Pharmacology. Drug treatments; ramipril; stage 2 hypertension; telmisartan; Trials in Special Populations
• ISSN: 0011-393X; 1879-0313
• DOI: 10.1016/j.curtheres.2005.12.007

A new oral fixed-dose combination (FDC) of telmisartan plus ramipril is being introduced in India for the treatment of patients with stage 2 hypertension. The aim of this study was to compare the effectiveness and tolerability of an oral FDC of telmisartan plus ramipril with those of an oral FDC of losartan plus ramipril in adult Indian patients with stage 2 hypertension. This multicenter, prospective, randomized, double-blind, Phase III study was conducted at 5 centers in India. Indian patients aged 18 to 65 years with uncomplicated stage 2 essential hypertension (systolic/diastolic blood pressure [SBP/DBP], >160/>100 mm Hg) were enrolled. After a 2-week placebo run-in period, patients were randomly assigned to receive telmisartan 40 mg plus ramipril 5 mg (T + R) or losartan 50 mg plus ramipril 5 mg (L + R), PO (tablet) QD (before the morning meal) for 8 weeks. Supine blood pressure (BP) was measured at 0 (baseline) and 8 weeks of treatment. The primary end point was the mean reduction from baseline in BP. Responders were classified as patients who had a DBP